A comparative evaluation of Losartan/Hydrochlorothiazide (fixed combination) versus Amlodipine monotherapy in patients with hypertension in Rohilkhand region

Abstract

The aim of this prospective randomized study is to comparatively evaluate
the antihypertensive efficacy of combination therapy   (losartan/hydrochlorothiazide) with monotherapy (amlodipine). This prospective randomized clinical study was carried out for twelve months (July 2012 – June 2013) and enrolled 250 newly diagnosed stage-I hypertensive patients (as per JNC-7 criteria), who attended medicine outdoor department of Rohilkhand Medical College & Hospital, Bareilly. Hypertensive patients between 18 - 70 years of age were included in the study. The patients were randomly divided into two groups. The Losartan / Hydrochlorothiazide (LST/HCTZ) group included 128 patients and amlodipine group (AMLO) included 122 patients. A total of 40 patients, 14 patients of LST/HCTZ group and 26 patients of AMLO group dropped out during the study. M/F ratio was 0.92:1, and urban/rural ratio was 1.06:1. Majority of patients were in the 41-50 years age group. Mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) were comparable between both groups, being 152.97 mm Hg and 95.05mm Hg for LST/HCTZ group and 153.27mm Hg and 95.27 mm Hg for AMLO group. Both mean SBP and mean DBP blood were statistically significantly reduced in each of the six follow ups in both the groups (p<0.001). The mean SBP was reduced from 152.97±0.45 to 121.65±0.81 and mean DBP was reduced from 95.05±0.17 to 76.28±0.51(in the sixth follow-up) in  LST/HCTZ group. Similarly mean baseline SBP 153.270±64 was reduced to
120.65±0.93 and mean baseline DBP was reduced from 95.270±38 to 75.54±0.67 after six months of therapy in AMLO group. The comparative evaluation of the two regimens revealed no statistically significant  difference (p>0.05) in both SBP and DBP reduction. Both LST/HCTZ and AMLO regimen were equally effective and well tolerated in lowering blood pressure.

KEY WORDS: Anti-hypertensive efficacy, Losartan/ hydrochlorothiazide combination, Amlodipine; Hypertensive patients